Skip to main content
. 2018 Sep 24;2018(9):CD011798. doi: 10.1002/14651858.CD011798.pub2

Wong 2005.

Methods
  • Study design: open‐label, parallel RCT

  • Study time frame: 2001 to 2002

  • Duration of follow‐up: 24 weeks

Participants
  • Country: Hong Kong

  • Setting: single centre

  • Inclusion criteria: insulin‐treated patients with type 2 DM; on CAPD therapy; stable glycaemic control (defined as HbA1c < 8% while insulin dosage is maintained at the same dose in the past 6 weeks)

  • Number: treatment group 1 (26); treatment group 2 (26)

  • Mean age ± SD (years): treatment group 1 (62.9 ± 7.3); treatment group 2 (61.6 ± 9.7)

  • Sex (M/F): not reported

  • Exclusion criteria: deranged liver function at baseline (ALT level > 2.5 times ULN); decompensated congestive heart failure

Interventions Treatment group
  • Rosiglitazone: 4 mg daily

  • Insulin: intermediate acting insulin. Insulin dosage was reduced by 10% at the start of the study to minimize the risk for hypoglycaemia


Control group
  • Insulin alone: intermediate acting insulin


Both groups
  • PD prescription was kept unchanged during the study period except during episodes of fluid overload as a temporary change.

Outcomes
  • Change in insulin dosage at the end of the study compared with baseline dosage

  • Change in C‐peptide, HbA1c, lipid, and high‐sensitivity CRP levels and adverse events

  • Adverse events: defined as liver function derangement, fluid overload, and need for blood transfusion

Notes
  • Funding source: GLaxoSmithKline

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer generalized list was used for randomisation
Allocation concealment (selection bias) Low risk "Investigators were unaware of the randomisation schedule when recruiting patients"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk "investigators and patients were not blinded during the follow‐up period"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk "investigators and patients were not blinded during the follow‐up period"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No discontinuations were reported
Selective reporting (reporting bias) Unclear risk The prespecified outcomes were available on a clinical trials database
Other bias Low risk Conflicts of interest: Rosiglitazone was provided by GLaxoSmithKline UK, with no other funding involved